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透皮贴剂特性质量研究方法及控制标准

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作为非侵入型药物递送系统,透皮贴剂可通过皮肤以固定剂量和可调节的速率递送药物,从而产生全身或局部的治疗作用。本文聚焦透皮贴剂关键质量属性,阐述其检测方法及试验中的关键点,同时参考国内外药典及现行政策法规,简述部分其他特性质量的检测方法及控制标准,以期为企业及相关部门完善质量检测体系及控制标准提供参考。
Quality control testing methods and standards for transdermal drug delivery systems
As non-invasive drug delivery systems,transdermal patches can deliver drugs through the intact skin at a fixed dose and a adjustable rate in order to product a systemic or local therapeutic effect.Focused on the key quality attributes of transdermal patches,the article illustrated the testing methods and how to control key points.It also briefly described the testing methods and standards of some other characteristics referring to pharmacopoeia,current policies and regulations in various countries,which provided a reference for pharmaceutical industries and relevant departments to improve the quality control methods and standards.

transdermal drug delivery systemtransdermal patchtesting methodquality standard

全丹毅、赵慧芳、刘羽恩、杨广强、陈华

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江苏集萃新型药物制剂技术研究所,南京 210032

中国食品药品检定研究院,北京 102629

经皮给药 透皮贴剂 体外释放 检测方法 质量标准

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(2)